Drugs, Biologics and Controlled Substance Law & Policy

Washington D.C. Attorneys and Advisors Offering Advocacy and Guidance From Early Development to Marketed Products

OFW Law advises our clients on every aspect of the regulatory process related to bringing a product to market, including: strategic planning and submission of dossiers for approval of New Drug Applications (NDAs), Investigational New Drug submissions (INDs), and Biologic License Applications (BLAs); clinical and nonclinical investigations; bioequivalency testing, labeling, chemistry, and manufacturing. Our drug practice is unique because we provide in-depth assistance beginning with the earliest development stages of drugs and biologics, continuing with the drafting and filing of approval applications for investigations, facilitation of final approvals of both innovator and generic drugs, and counsel regarding the post-approval regulation of marketing and manufacturing of the product.

Highlights of our practice include:

Drug Exclusivity Litigation

At OFW Law our attorneys have handled more litigation involving FDA and generic drug approval requirements than any other law firm. When protection of market exclusivity becomes an attempt to "game" the system, we help clients submit trade complaints to regulatory authorities.

Over-the-Counter Drugs

We advise firms on marketing products under over-the-counter (OTC) tentative and final drug monographs, or as competitors to "old" drugs that are currently marketed.

Welcome to OFW Law

OFW Law provides legal, regulatory, and bipartisan government affairs representation to companies, individuals, and trade associations in the agriculture, food, drug, medical device, and health care industries, including representation of the interests of modern agriculture in matters involving environmental law.

The experience of our attorneys and policy advisors, who have backgrounds in government, industry, science and medicine, coupled with proactive, responsive and effective service, has helped OFW Law build a reputation for depth and subject matter expertise. Read More

Awards and Associations

Recent Blog Posts

FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional Adulteration”…
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As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing…
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